Clinical Investigation to Assess the Efficacy and the Safety of VisuXL® Gel Administered in Patients Affected by Moderate DED

NCT04485533 | Unknown

• 1 other identifier: VF-OS-004/2019
• Study Type: interventional
• Target: 90
• Locations: 3 countries
• Sites: 3

Brief Summary

This is a post-market, european multicenter study. This is a randomized, cross-over, double blind study with competitive enrolment, aimed to enroll a total of 90 patients with a diagnosis of moderate dry eye disease (DED).

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• Tear Break-Up Time (TBUT)

  To evaluate the effect of treatment with VisuXL® GEL versus HYLO® on the stability of the tear film by Tear Break-Up Time (TBUT) in patients affected by moderate dry eye disease (DED).

  through study completion, an average of 2.5 months

Secondary Outcomes (9)

• Stability of the tear film assessed by NIBUT (Non-invasive Break-Up Time)

  through study completion, an average of 2.5 months

• Functional Visual Acuity (FVA)

  through study completion, an average of 2.5 months

• Tear secretion

  through study completion, an average of 2.5 months

• Burning, foreign body sensation, itching, and photophobia symptoms of DED assessed by Visual Analogue Scale (10 points VAS)

  through study completion, an average of 2.5 months

• Conjunctival inflammation assessed by staining grade with Van Bijsterveld Scale

  through study completion, an average of 2.5 months

Study Arms (2)

VisuXL® Gel/HYLO®

EXPERIMENTAL

Patients treated with VisuXL® ophthalmic gel for the first 30 days (1 treatment period) and with HYLO® for the second 30 days (2 treatment period).

Device: VisuXL® Gel; Device: HYLO®

HYLO®/VisuXL® Gel

ACTIVE COMPARATOR

Patients treated with HYLO® for the first 30 days (1 treatment period) and with VisuXL® ophthalmic gel for the second 30 days (2 treatment period).

Device: VisuXL® Gel; Device: HYLO®

Interventions

VisuXL® Gel DEVICE

VisuXL® ophthalmic gel, available in a multidose 10ml bottle without preservatives based on Coenzyme Q10, Vitamin E TPGS and cross-linked sodium carboxymethylcellulose. Dose/dosage: 1 drop per eye twice a day.

HYLO®/VisuXL® Gel; VisuXL® Gel/HYLO®

HYLO® DEVICE

HYLO® ophthalmic solution, a phosphate- and preservative-free sterile eye drops containing 2 mg/ml of hyaluronic acid sodium salt, a citrate buffer, sorbitol and water. Dose/dosage: 1 drop per eye twice a day

HYLO®/VisuXL® Gel; VisuXL® Gel/HYLO®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient Informed consent form (ICF) signed.
• Males and Females aged ≥18 years at the time of the signature of ICF.
• Patients with moderate dry eye disease (DED) according to IDEEL questionnaire (score ≥51 and ≤64) and diagnosed at least 3 months before enrolment.
• No use of other tear substitutes in the 5 days prior to enrolment, except for refresh solutions.
• TBUT value \<6 sec.
• Willing to follow all study procedures, including attending all site visits, tests and examinations.
• Women must agree to be using two forms of effective contraception, be post-menopausal from at least 12 months prior to trial entry, or surgically sterile.

You may not qualify if:

• Patients with a mild or severe dry eye disease (DED) according to IDEEL questionnaire (score ≤50 and ≥65, respectively).
• Use of ophthalmologic products in the 14 days prior to enrolment, except for refresh solutions and stable glaucoma treatment.
• No previous history or presence of any disease involving cornea or conjunctiva.
• Sjӧgren syndrome.
• History or active cicatricial conjunctivitis.
• History of ocular surface burns.
• Use of contact lenses.
• Corneal refractive surgery 1 year post-operative.
• Any ocular surgery in the previous 3 months preceding the study.
• Unstable glaucoma (treatment changes in the last year).
• Any macular or retinal disease that could impact visual acuity.
• Best corrected visual acuity (BCVA) below 20/40.
• Blepharitis treatment started less than 3 months before enrolment.
• Neurological, neurodegenerative or cerebrovascular conditions.
• Any clinically significant history of serious digestive tract, liver, kidney, cardiovascular, cancer or hematological disease.

Sponsors & Collaborators

• VISUfarma SpA: lead

Study Sites (3)

Hôpital Morvan

Brest, Finistère, 29200, France

Location

ASST-Santi Paolo e Carlo-Presidio San Paolo

Milan, MI, 20142, Italy

Location

Hospital Clínico San Carlos de Madrid

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: July 24, 2020
• Study Start: July 6, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: July 24, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); ES (1); IT (1)